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New active surveillance more individualized

For Low Risk Prostate Cancer, Personalized Monitoring An Option

Active surveillance may be a viable option for some men with prostate cancer. Regular tests and careful tracking of any changes in the patient's disease risk over time are imperative to ensure good outcomes, according to researchers in Toronto presenting at the annual meeting of the American Urological Association (AUA).

Active surveillance is typically offered to men with prostate cancer if biopsy results, staging and PSA doubling time all indicate that the tumor is so small and slow-growing that it is unlikely to develop into fatal illness within the man's lifetime. For a man with "low-risk" prostate cancer it is an attractive option, allowing him to delay or avoid radical treatment and adverse effects on quality of life.

First, patients must be properly selected for slow-growing disease. Then they must be carefully monitored and offered definitive therapy promptly if the picture changes. So patients on active surveillance require periodic screenings. Even indolent, slow-growing prostate cancer may not remain static.

The Toronto study has been focused of late on what needs to go into the monitoring process to avoid doctor and patient from being blind-sided by disease progression. The aim of the current research is to determine the best intervention parameters -- at what point physicians should intervene and offer more aggressive treatment options.

Study results show that patients who experience a prostate-specific antigen (PSA) doubling time of less than three years or a pathologic progression to Gleason 4+3 are at a higher risk for disease progression and require more aggressive treatment.

When the study began in 1995, researchers offered Active surveillance to prostate cancer patients with favorable risk parameters (Gleason less than or equal to 6, and PSA less than or equal to 10) as an alternative to radical treatment. Patients were followed with regular PSA testing and periodic biopsy. Intervention was offered based on PSA kinetics (i.e. velocity or rate of doubling time) or tumor grade progression measured by Gleason score.

In 2000, the study was restricted to favorable risk disease. Definitive intervention was offered to those patients with a PSA doubling time of less than three years, Gleason score progression (to 4+3 or greater) or unequivocal clinical progression. Of the 453 patients on the program:

Median age is currently 70

Median follow-up is 7.2 years

Overall survival is 83%

Prostate cancer survival is 99%.

35% (roughly 1 out of 3 patients) have been reclassified as higher risk and offered definitive therapy.

5 of the 453 patients have died of prostate cancer

The most common indications for treatment were a PSA doubling time of less than three years or Gleason upgrading. Of the 137 patients treated surgically, the PSA failure rate (rising PSA) was 52 percent. Patients with biochemical failure after radical therapy constitute 15 percent of the overall study group. The ratio of non-prostate cancer to prostate cancer mortality was 16.

"In terms of evaluating the outcome from any prostate cancer therapy or watchful waiting protocol, the duration of observation is critical. Although 7.2 years of follow-up, as noted here, seems long, many investigators would be careful with any conclusions until the follow-up time exceeded 10 years," said Kevin T. McVary, MD, an AUA spokesman. "Regardless, watchful waiting is an appropriate and commonly practiced care for selected men with prostate cancer."